Director/Sr. Director of Clinical Development

Dragonfly Therapeutics is seeking a knowledgeable, experienced, and motivated individual to join our team and support clinical stage activities. Reporting to the Head of Development, this role will be responsible for working closely with the Asset Lead, to develop and implement strategies for efficient high-value clinical development of cancer immunotherapy drug candidates, leading to clinical proof of concept. He/she will also be responsible for planning, managing, coordinating and tracking all clinical activities associated with specific clinical development programs for novel drug candidates. Must be hands-on, clinical operations professional with experience in clinical research who is nimble, eager to learn, and thrives in a fast-paced, collaborative environment.

Responsibilities:

• Contribute to early stage (phase 1-2) clinical trial design for novel, first-in-class tri-specific antibodies or cytokine programs for treatment of cancer
• Write clinical trial synopsis and protocols and associated documents
• In collaboration with the clinical operations team, contribute to selection of clinical sites, investigators and support project-related education of investigators, study site personnel, and study staff
• Support all clinical aspects related to specific programs
• Support clinical study teams, monitor clinical trials (medical monitoring), and review, analyze, interpret, and communicate safety and efficacy data
• Contribute to clinical reports and publications
• Present at scientific and medical advisory board meetings and at regulatory meetings
• Develop and maintain cross-functional relationships with academic investigators, pharmaceutical partners/sponsors, CROs, KOL’s, and patient advocacy groups
• Contribute to company’s planned regulatory filings including drafting clinical sections for INDs and other related documents
• Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholders
• Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards
• Participate in clinical development contributions to due diligence or other business development activity
• As required by program needs, contribute in partnership with Discovery and Translational Medicine colleagues to the design and implementation of translational strategies

Qualifications:

• MD (hematology/oncology) or MD/PhD (hematology/oncology) with at 3-5 years successful track record in biotech or pharma in Medical Director roles in oncology and cancer immunotherapy (title commensurate with experience)
• Pharmaceutical drug development experience gained through front-line involvement in development of IO drugs to clinical PoC, and preferably to the market, in the US or EU
• Ability to learn and to support complex clinical research programs with minimal direction
• Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols
• Preferred candidates have both clinical experience and a research background in hematology/oncology, immunology or immunotherapy involving cytokines or other immune modulators
• Ability to work well with others, and to bring out the best in others on a cross-functional team; highly collaborative, team oriented and decisive
• Excellent communication and presentation skills are essential
• Willingness to travel to clinical sites and home office as required and necessary in support of the project(s)